Who Should Register: Pharmaceutical manufacturers, contract manufacturers, API
producers, repackagers, relabelers, and other drug establishments marketing or
distributing products in the United States.
Governing Authority: FDA Establishment Registration requirements are governed by
21 CFR Part 207 and FD&C Act §510 (21 USC 360).
Submission Method: Registration and drug listing information are submitted
electronically through FDA-approved systems, including CDER Direct and the FDA
Electronic Submissions Gateway (ESG), using Structured Product Labeling (SPL) standards.
Essential Requirements: A valid DUNS Number, a registered business address, and a
designated U.S. Agent for foreign establishments are required before registration can be
completed.
Registration Outcome: Upon successful submission, the FDA assigns a Facility
Establishment Identifier (FEI) and issues official registration confirmation, typically
within 24–48 business hours.
Annual Renewal: FDA establishment registrations must be renewed each year during
the mandatory renewal period from October 1 through December 31.
Foreign Facility Requirement: Non-U.S. establishments are required to appoint a
qualified U.S. Agent with a physical U.S. address to facilitate regulatory
communications with the FDA.
Comprehensive Support: Our end-to-end registration service includes document
review, submission management, compliance guidance, and U.S. Agent representation for
foreign facilities.
Consequences of Non-Compliance: Failure to comply with FDA registration
requirements may result in products being classified as misbranded, issuance of FDA
Warning Letters, Import Alerts, Detention Without Physical Examination (DWPE), shipment
refusals, product seizures, injunction actions, and removal from major e-commerce and
payment processing platforms.
